Reported Dec 25, 2024 · Ongoing
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
- Lot codes and dates
UDI/DI 20193489005339 (case)10193489005332 (each)All Lots
- Amount recalled
- 768 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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